Information Systems Leader

Within Drug Product Manufacture

The Arena

Pharmaceutical Development is accountable for the design of innovative, efficient and robust drug products as well as for the manufacture processes for both drug substance and products. The accountability also includes the supply of products for safety and clinical trials and the generation of information and knowledge to ensure regulatory approval of new products.

Drug Product Manufacture (DPM) in Gothenburg manufactures investigational products for medicines in development phase. We use a broad range of techniques and manufacture solutions/suspensions (oral/inhaled), parenteral solutions, capsules, tablets and inhalers to support AZ clinical phase I/II studies including patients around the globe. We are thereby a vital part of the Pharmaceutical Development Supply Chain organisation. At DPM in the GMP (Good Manufacturing Practice) arena, you will make an important contribution in delivering clinical results and new medicines. You will find a vibrant team in which continuous improvement and effective collaboration are high priorities.

The role

This is a technically advanced role, with no direct reports, significantly contributing to the manufacturing and packaging of drug product for clinical studies.
The role holder has strong IS competence, credibility and ability to give assured direction and provide expertise regarding integrated computerized systems supporting facilities and equipment on Mölndal site.

As an important member of the GMP Facility Governance Board and DPM Quality and Continuous Improvement network in Gothenburg, the role holder collaborates closely with internal and external partners ensuring operational status of complex IS/IT supported manufacturing equipment and its compliance with GMP. This includes acting as System Manager and/or Super user for some of the systems, proactive interaction with the System Owners and Managers of other relevant systems as well as support organisations.
Collaboration with other relevant System Specialists/Super Users is important to assess the impact of current business needs or changes to identify improvements. The role holder will contribute to validation and efficient implementation of enhancements and upgrades as well as development/maintenance of procedures and training materials.

Requirements

BSc/MSc in IS/Engineering/Pharmacy or equivalent experience.
We are looking for a professional employee with high IS knowledge and project leadership skills who has the ability to operate independently in good collaboration in a culturally diverse, complex and changing environment. The applicant should have a good understanding of developments within the industry and how they impact the function.

You will have knowledge of cGMP and appreciation of principles, applications and management of IS/IT systems and current IS Quality Management standards. Excellent documentation skills both in English and Swedish. Interest in manufacturing equipment and automated systems is a benefit.

More information

For more information about the position please contact: Jonas Ödman or Gunnar Haeffler at +46 31 776 10 00.

Welcome with your application no later than August 12, 2016.